Seroxat/Paxil Study 329 : Republic to Empire

“….I asked Rob whether his company would have launched an internal damage limitation exercise like GSK/SKB did around the Panorama programs about paroxetine: Of course he said – and that it would have probably been successful. Employees would have been reassured that the company – their company- would never have deliberately harmed children. Success of the exercise would have been sustained partly through loyalty to the company but mainly because no one could afford to think too closely about whether it was true. Ask too many questions and you would be out on your ear with no chance of getting a reference for a future job…”

This is an interesting blog post by Sally McGregor, on Prof Healy’s blog.

Basically it seems that Sally is aiming to give readers a view from the other side of the pharma fence (so to speak). Regular readers will know very well what side of the fence, I’m on.

In her post, Sally explains the state (and mind set) of the industry at the time- and she puts into context -how bad stuff like Seroxat study 329, or the Zyprexa scandal, happens..

And effectively how unethical decisions from the top, trickle down, leading to harm to consumers…

I’m not quite sure I completely go along with the view from this perspective (for reasons which I will explain later) however it’s an interesting and insightful read nonetheless and well worth reading…

Study 329: Republic to Empire

Editorial Note: This post is from Sally MacGregor. In depositions and lectures I commonly state that I have had more support and information from colleagues working for industry than from clinical colleagues.

I loved the analysis of the derailment of medicine and research through the comparison between a Republican and Empire structure, and the take-over of the former by the latter (See Data Wars & Minions No Longer). It highlighted a moral/ethical dilemma that I thought about throughout the riveting unrolling of Study 329 and its re-write. How do good people become corrupted?

Unless you buy into the idea that every one of the million or more people who have ever worked for a drug company is inherently lacking any moral compass, then it is imperative to wonder what happens such that one giant corporation can ruthlessly and without any expression of regret kill people in the interests of profit. Corporations aren’t some weird, otherworldly entity, a life form that has developed somewhere in the outer reaches of the galaxy, like the Daleks that terrified me at the age of 8. Corporations are people. From the chief executive down to the people who make the products on a factory line – they are all human.

One might attribute hubris, overweening greed and psychopathy to those at the very top but not, I think, to all the tens of thousands of employees. Thoughts of Nazi Germany spring to mind – the millions of ‘ordinary’ Germans who kept quiet, or turned a blind eye to the persecution of the Jewish people and the Holocaust. Maybe there is something similar at work, but it doesn’t quite fit the whole picture for me.

I can describe the last throes of Republic and the transition to Empire from a personal perspective: when my husband was offered his first job after university in the early 1980s, with a now defunct American pharmaceutical company, we thought he was going to be putting his biochemical training to good, practical purpose – albeit in animal medicines. Dealing with problems like enteritis in pigs or finding better ways of managing flea infestations in cats and dogs. It wasn’t exactly noble – but it seemed a useful way of earning a crust.

At that time, in the early 1980s, the animal health division was headed by a veterinary surgeon and many of the older scientists at American HQ were exiles from Nazi Europe. One, Irv, long since dead, had escaped from Germany in 1939, and met and married a fellow escapee who had got out on the Kindertransport scheme, here in the UK. They’d settled on the East Coast of the US, near the company’s research HQ in Philadelphia when Irv began work for the company as a chemist. They stayed there for 50 years. He was a scrupulously honest person who sometimes drove his colleagues mad with his meticulous attention to small detail. He was a Democrat through and through, and utterly horrified by the corporate dishonesty revealed during the Enron scandal. Music was his first love but he was always ready to talk politics, books and the theatre. He and his wife were humane, cultured people. They were also deeply grateful and loyal American citizens. The only time we ever differed was when they were both shocked to the core by a spate of flag burning in the early 1990: some protest or other in the US, which seemed perfectly low key, and quite amusing to us but really shocked them both. I wish I could discuss what has now emerged about the embedded corruption of Big Pharma with Irv.

During the 1990s the pharmaceutical industry sank into turmoil: Rob’s company was, I think, the first to be the subject of a hostile take-over by another US giant. It wasn’t a pleasant way to lose your job: there were over 3,000 people working at the UK base alone. The managing director and division heads in the US knew about the bid from AHP and had been fighting secretly for the company’s survival. They lost.

Rob and everyone else turned up for work one Monday to be met by personnel (as Human Resources used to be known) and representatives from the invading forces. All the managers were asked for their car keys, escorted to their desks and watched while they collected the photos of the kids and any other personal items. Then they were escorted rapidly off the site and sent home. Rob was back by 10 am. They were watched as they cleared their desks, in case angry and upset (now ex) employees scooped up papers with data and information that could be used in revenge against the invading Empire, or those with IT know-how might bugger the computer system with a rapidly inserted virus.

Redundancy the American way was a humiliating experience. And nothing was ever the same again. No one ever felt secure from that point onwards.

The UK site was raped and pillaged by the invading hordes, its commercial assets split and sold off to other companies in a frenzy of ‘reorganisation’. The UK base had been the second biggest employer in a large area, which has never recovered, economically. The site was gradually torn down; the land sold piecemeal for housing and where Rob’s office building stood there is now a Drive-Thru Kentucky Fried Chicken outlet, which employs 30 people on zero-hours contracts.

Some like Rob found another job, some never did. Rob went to work for a Swiss company that, within 6 months had merged with another to make, at that time, in 1996, the biggest pharmaceutical company in the world. We’d faced redundancy twice within a year. At the time we had two children about to go to university, our house like many others in the UK was in negative equity due to soaring interest rates and a collapsing housing market. We were financially vulnerable – like everyone else. When he was offered a job at HQ we had little real choice, despite the fact that it was in Switzerland.

Scientists and department heads were replaced by people with backgrounds in ‘business management’, and PhDs gave way to MBAs as the gold standard qualification for employment. Pressures grew to maximize profits: it would be foolish to pretend that loyalty to the company hadn’t always been a requirement, and that the profit margin had always came first – but from the mid 90s onwards the moderating influence of people like Irv just evaporated. The atmosphere at work became highly focused on meeting targets, deadlines, and budgets. There was simply no room for skepticism or questions: once you were perceived as awkward you knew you were likely to be kicked out.

The people who had to go out and sell the products on the frontline – the sales force – were probably subject to the most intense pressure of all. And were most vulnerable to being sacked. I read the Eli Lilly internal documents posted on Mad in America, detailing operation Viva Zyprexa! The Empire was out to conquer new lands – primary care physicians. The crib sheets detailing how the sales force were to lie about the fact that Zyprexa caused diabetes make grim reading (particularly grim for me maybe, as I developed diabetes and lipid dysregulation after years of Zyprexa/olanzapine). But as sickening is the appalling cheerleading at the ‘product launch’ meetings, the crude offsetting of one team against another and the psyching up of the reps to ‘Go out there and kick ass!’ OK, maybe reps aren’t the brightest people in the world but they were being groomed for aggressive selling, just as 16-year-old lads are groomed to kill when they enter the army. A macho, bullying environment where you either sink or swim. No room for people who might have qualms about the morality of what they are being asked to do and who have families to care for and mortgages to pay every month.

I asked Rob whether his company would have launched an internal damage limitation exercise like GSK/SKB did around the Panorama programs about paroxetine: Of course he said – and that it would have probably been successful. Employees would have been reassured that the company – their company- would never have deliberately harmed children. Success of the exercise would have been sustained partly through loyalty to the company but mainly because no one could afford to think too closely about whether it was true. Ask too many questions and you would be out on your ear with no chance of getting a reference for a future job.

If this sounds like an apologia for those working in the pharmaceutical industry – it isn’t. Some people do very bad things in any arena which are simply unforgiveable on any level: it’s hard to forgive the doctors and nurses who propped up a failing, abusive hospital in Mid Staffs by ignoring the pain and distress of patients. It’s very hard for me, remembering some of the casual brutality to which I was subjected as an inpatient in several mental hospitals. Even harder to think that the industry which bought our food and paid the bills wreaked such appalling damage on our family.

But unless you dig under the surface and wonder how such things happen, think about the context: the atmosphere of fear engendered by bullies who are probably being bullied themselves, then it’s too easy just to be angry. Anger is good – but not enough on its own. I think it’s important to put Study 329 in its cultural and economic context; try and peel away the layers of the onion and get at some understanding of why what happened, happened. Saying ‘oh that’s just capitalism in action’ is true, but in the end offers no chance of doing things differently at some point.